Effectiveness of Fascial Manipulation for Chronic Low Back Pain. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- disabilty level, evaluated with the Roland and Morris Disability Questionnaire
研究概览
简要总结
The purpose is to evaluate the effectiveness of a physiotherapy program for chronic low back pain. We'll randomize more about 35 patients in two groups. Both groups will receive an 8 physioterapy intervention in 4 weeks, in particular the first group (study) will receive 4 Fascial Manipulation treatment combined with 4 session of a standard approach (mobilization and stretching exercises); whereas the second (control) will receive only the standard approach.
详细描述
All patients were assessed and randomised by a physician. The control group intervention concerned of: relaxation of lumbar and respiration muscles, stretching for posterior muscular chain and hip flexors, assisted/active mobilization of lumbar region in sagittal plane and rotation, exercises to improve proprioception of lumbar spine, active and progressive movement of lumbar spine in anterior flexion, extension, lateroflexion and rotation, active exercise for lumbar stabilizers muscles, occupational training for activity of daily living, indications and recommendations for correct postures. The study group intervention received 4 manual intervention on deep fascial tissues, according to fascial manipulation tecnique, providing a specific motor and manual assessment, and a deep manual intervention over specific fascial alteration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a chronic low back pain (more than 7 weeks)
- •age between 20 to 60 years old
排除标准
- •presence of neurological red flags
- •continuative assumption of drugs for low back pain
- •no positive imaging for spine lesions (fractures, spondilolistesi,
- •vascular desease (aneurism abdominal aorta)
- •secondary lesions (oncological desease)
- •rheumatic systemic desease
- •any other neurological desease which could compromise the partecipation to the program exercise
结局指标
主要结局
disabilty level, evaluated with the Roland and Morris Disability Questionnaire
时间窗: from the first evaluation, at the end of the treatment
we'll compare the baseline data (the first evaluation), with data at the end of the treatment, and with at every fullow up (30 and 90 days from the end of the treatment)
次要结局
- pain and social activity level evaluated with Brief Pain Inventory.(from the first evaluation, at the end of the treatment)
- quality of life, evaluated with SF-36(from the first evaluation, at the end of the treatment)
- pain, assessed with visual analogical scale(at the first evaluation, at the end of the treatment)